Skin Disease Education Foundation (SDEF) 2011: Hawaii Dermatology Seminar

WAILEA, HAWAII – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator's Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator's Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator's Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator's Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator's Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator's Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator's Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator's Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator's Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator’s Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator’s Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator’s Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator’s Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator’s Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator’s Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator’s Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator’s Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator’s Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.

Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.

This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.

There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.

In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.

Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.

Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.

"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.

Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.

Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.

Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.

This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.

There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.

In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.

Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.

Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.

"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.

Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.

Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.

Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.

This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.

There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.

In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.

Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.

Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.

"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.

Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.

Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.

Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.

This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.

There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.

In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.

Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.

Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.

"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.

Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.

Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.

Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.

This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.

There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.

In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.

Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.

Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.

"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.

Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.

Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII  – Physicians now have access to two useful new products for the acne toolbox, benzoyl peroxide 9.8% emollient foam and clindamycin phosphate 1.2%/tretinoin 0.025% gel.

Benzoyl peroxide 9.8% emollient foam is a novel short-contact product that offers practical advantages over other formulations of benzoyl peroxide. And clindamycin phosphate 1.2%/tretinoin 0.025% gel combines two acne medications in a single product that has been shown in large randomized trials to be more effective than either alone, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The over-the-counter medication benzoyl peroxide 9.8% emollient foam (BenzEFoam Ultra) was created in response to the unpredictability of current benzoyl peroxide washes. When a patient puts on one of these older products and then jumps into the shower, it is unclear how much stays on the skin and how much washes down the drain. In addition, bleaching of towels and clothes is a problem with the leave-on benzoyl peroxide products, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The new benzoyl peroxide 9.8% foam is applied to nonmoistened skin, massaged in for 20 seconds, left on for 2 minutes, and then washed off. "Theoretically the patient could put it on, brush his or her teeth, get into the shower, and wash it off. That’s how long it needs to stay on the skin," Dr. Baldwin said.

This is the first benzoyl peroxide wash supported by substantive evidence of efficacy, she added, citing a recent 2-week, open-label crossover study conducted by Dr. James Leyden of the University of Pennsylvania, Philadelphia. The study involved 20 patients heavily colonized with Propionibacterium acnes on the upper back. Quantitative bacterial cultures demonstrated that after 1 week of treatment with the short-acting 9.8% foam, patients experienced nearly a 1-log decrease in P. acnes counts compared with baseline, which translates into an 86.5% reduction. After 2 weeks using the benzoyl peroxide 9.8% emollient foam, the participants demonstrated a 1.67-log reduction, equivalent to an impressive 98.3% decrease in P. acnes.

There were no tolerability issues in the study. Bear in mind, however, that results obtained on the upper back cannot necessarily be generalized to the face, noted Dr. Baldwin.

In a phase III trial of clindamycin 1.2%/tretinoin 0.025% gel, 36.3% of 476 treated patients experienced at least a 2-grade improvement on the Investigator’s Global Assessment scale at 12 weeks, the primary study end point. That was a significantly better result than the 26.6% rate in 467 patients assigned to clindamycin gel, the 26.1% rate in 464 patients on tretinoin gel, or the 20.2% rate in 242 participants on a vehicle gel.

Patients using the combination product experienced a mean 60.4% reduction in inflammatory lesions, superior to tretinoin alone, and a 51% decrease from baseline in noninflammatory lesions, which was superior to clindamycin alone.

Tolerability of the combination gel was good across three pivotal trials totaling more than 3,800 randomized subjects. Side effects in the clindamycin gel and vehicle study arms were virtually identical, with 3% of each group experiencing one or more irritation-type adverse events, such as dryness or redness. The side effect rate in the combination gel and tretinoin-only study arms was higher, at 13% in both groups.

"Clearly, the tretinoin appears to be the reason why there’s a little bit of irritation in the combination product. Tretinoin causes irritation; that won’t come as a surprise to anybody. But it’s very low grade and occurs for the first 1-2 weeks, just as you’d expect, with very few discontinuations," Dr. Baldwin said.

Combination gel products containing clindamycin 1.2% and tretinoin 0.025% are marketed as Veltin by Stiefel and as Ziana by Medicis.

Dr. Baldwin declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children’s Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children’s Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children’s Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children's Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children's Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children's Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children’s Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children’s Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – With head lice showing increased rates of resistance to popular over-the-counter rinses, other alternatives are necessary, according to Dr. Albert C. Yan.

Two reasonably effective, nonpesticide, nonneurotoxic therapies that kill Pediculosis humanis capitis by asphyxiation are a prescription benzyl alcohol 5%/mineral oil product called Ulesfia lotion (Shionogi Pharma) and an OTC Cetaphil cleanser (Galderma) encasement technique, he said at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF):

• Ulesfia lotion. The benzyl alcohol in Ulesfia lotion stuns the lice spiracles, or breathing holes, so they are frozen in the open position. The lice then drown in the mineral oil vehicle, explained Dr. Yan, a pediatric dermatologist at Children’s Hospital of Philadelphia.

Ulesfia lotion is approved for use in patients aged 6 months and older. It is applied for 10 minutes before being washed out. Because it is important to fully saturate the hair, the quantity of Ulesfia lotion used depends upon hair length. This is a nonovicidal therapy; retreatment is required 1 week later.

In two phase III trials, 127 Ulesfia-treated patients had cure rates of 86% and 97% a day after their second treatment, with no significant adverse events.

©CDC/Reed & Carnrick Pharmaceuticals

• Cetaphil gentle skin cleanser. The dry-on encasement technique involves application to the hair and scalp, a wait of 2 minutes, then a comb out. Eight hours later the hair is washed with regular shampoo. This procedure is repeated once weekly for 3 weeks. In two open studies totalling 133 patients, the cure rates were 95% and 97%.

Fomite management should be a component of either therapy. Clothes and bedding should be placed in a hot dryer for 10 minutes, and combs should either be run through the dishwasher or placed in isopropanol for 10 minutes.

Among the other alternative therapies Dr. Yan discussed were:

• Home remedies. Popular home remedies for head lice include mayonnaise, olive oil, butter, and vinegar. The Centers for Disease Control and Prevention has reported that there is no clear scientific evidence that any of these are effective. However, Dr. Yan noted that an in vitro study of lice and egg survival with home remedies found petrolatum to be the most effective, with 38% of lice remaining viable at 24 hours and just 6% of eggs hatching, compared with 98% of lice being viable and 56% of eggs hatching with olive oil, for example (J. Pediatr. Nurs. 2004;19:393-8).

• Malathion and spinosad. Rates of resistance to permethrin and pyrethrins now approach 50% in some areas. For resistant cases, in addition to the topical suffocants, Dr. Yan said he favors malathion (Ovide lotion, Taro Pharmaceuticals) and a new prescription product, spinosad 0.9% (Natroba, ParaPRO). However, malathion is indicated only for patients at least 6 years old, and spinosad is indicated only for those at least 4 years of age, whereas Ulesfia is indicated for children as young as age 6 months.

Malathion has good efficacy but a strong odor. Plus, it is flammable, so after applying it patients need to steer clear of the barbecue grill, cigarettes, and other flaming objects. Dr. Yan said he has patients leave it on for just 1-2 hours instead of overnight as labeled, because of data showing the briefer exposure period is equally effective.

Spinosad 0.9% received Food and Drug Administration marketing approval in January. This is a widely used crop pesticide that is both pediculicidal and ovicidal, yet has minimal mammalian toxicity. The topical suspension is left on for 10 minutes, then washed out with no need for combing in order to achieve efficacy.

Dr. Yan said he is a consultant to Topaz and has received research grants from Pierre Fabre and Promius Pharma. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Physicians will likely gain a novel short-course field therapy for multiple actinic keratoses next year.

Ingenol mebutate (Leo Pharmaceuticals) hit all of its end points in two phase III clinical trials. One trial was conducted in patients treated for fields of multiple actinic keratoses (AKs) on the head and neck, the other in patients with clusters of AKs anywhere else, Dr. Theodore Rosen said at a seminar sponsored by Skin Disease Education Foundation (SDEF).

Median reductions in AKs in these pivotal trials were comparable to results reported with other field therapies, such as imiquimod and 5-fluorouracil. What is remarkable about ingenol mebutate, however, is these outcomes were achieved with only 2 days of once-daily therapy for non–head and neck AKs and 3 days of therapy at a lower concentration for AKs on the head and neck, noted Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

In contrast, the original regimen for the 5% imiquimod dermatologists have been using since its 2004 marketing approval for AKs entails a full 16 weeks of twice-weekly therapy. That being said, last year, the FDA approved a new, shorter-duration formulation of imiquimod which Dr. Rosen said was a better product than the traditional 5% version.

Ingenol mebutate is a diterpene ester derived from the sap of a plant, Euphorbia peplus, traditionally used by Australian aborigines for topical treatment of various skin ailments. Ingenol mebutate’s mechanism of action is not fully understood, but involves initial cell necrosis because of mitochondrial disruption followed by granulocyte-dependent cytotoxicity. Immune upregulation also appears to be involved, Dr. Rosen explained.

Non–Head and Neck AK Study. The phase III non–head and neck AK study involved 256 patients randomized to 2 consecutive days of once-daily ingenol mebutate 0.05% gel or placebo applied to up to a 25-cm² area of skin with four to eight visible AKs. The ingenol mebutate group showed a complete clearance rate at day 57 of 27.8%, compared with 4.7% for placebo, and a median 67% reduction in AKs.

The 27.8% complete clearance rate is nothing to write home about, but the 67% reduction in AKs is quite impressive, particularly for a 2-day therapy, according to Dr. Rosen, who was an investigator in these and other AK clinical trials.

“That 67% median reduction is very nice, and it’s really the most accurate measurement because it tells you how many of these things are going to go away by treating the field,” Dr. Rosen said.

The complete clearance rate was highest on the chest, followed by the arms, legs, back of hand, and back.

Side effect rates were low at 1%-2%, and consisted of burning, irritation, pain, and other symptoms that are associated with most field therapies for AKs. Interestingly, the peak incidence of the skin side effects was not until day 8.

“You’ll have to prepare patients for the fact that almost a week after they’re done with therapy, they may suddenly look worse,” he noted.

The product labeling will limit treatment to areas of 25 cm² or less because that is how the pivotal trials were done. “If you want to treat more than 25 cm², you’ll probably be off-label, but we do that all the time,” he said.

In an exploratory trial in which investigators treated AK fields of 25, 50, 75, and 100 cm² on the dorsal arms using 0.05% ingenol mebutate applied once daily for 2 days, cumulative local skin reaction scores correlated with the size of the area treated. Even in patients who underwent treatment of 100 cm² of involved skin, side-effect scores returned to baseline by 2 months. Most patients tolerated even the most severe reactions, he noted.

Head and Neck AK Study. The phase III head and neck AK trial involved treatment of areas up to 25 cm² in 264 patients. This trial featured several drug concentrations and durations; the one that produced the best outcomes and will move forward to the marketplace is 0.015% once daily for 3 days. It yielded a complete clearance rate of 50% on day 57, and an 85% median reduction in AKs, according to Dr. Rosen.

With two different concentrations of ingenol mebutate likely to be approved for application at different sites, physicians will need to remain vigilant regarding possible dispensing errors or patient misuse, he said.

Imiquimod. While ingenol mebutate’s duration of efficacy remains unknown, that is not the case with imiquimod.

The new imiquimod 3.75% cream (Zyclara), approved last year for treatment of AKs, provides clear benefits over the older 5% formulation in terms of convenience, and with comparable efficacy.

Instead of the traditional 16 weeks of therapy, the 3.75% cream is used daily for 2 weeks, followed by a 2-week rest, then another 2 weeks of therapy, for a total 6-week treatment course. And the imiquimod 3.75% cream is approved for treatment of the full face or balding scalp, unlike imiquimod 5%, whose approved indication is limited to a much smaller area of 25 cm², Dr. Rosen said.

In the pivotal trial for imiquimod 3.75%, 160 treated patients showed a complete clearance rate of 35.6% and a median 81.8% reduction in AKs 8 weeks after the final treatment. That is near-identical to the 83.3% reduction noted in an earlier trial of 215 patients treated with imiquimod 5%.

Dr. Rosen said field therapy makes sound sense in patients with multiple AKs in the same area of the skin.

“When you have a patient with [a lot of] AKs, then all the skin in between those AKs is no more normal than the AK skin; it just hasn’t manifest yet. That’s where field therapy comes in,” he explained.

As much as he likes field therapy, though, Dr. Rosen stressed that the emerging new paradigm for treatment of patients with multiple AKs is combination therapy. This can take the form of either a field therapy followed by individual lesion-directed therapy such as cryotherapy, or lesion-directed therapy followed by a field therapy. There are numerous possible combinations. Insurance reimbursement can be a problem for now, but payers will eventually have to come around to the new paradigm.

“The bottom line is for every study where field therapy is combined with lesion-directed therapy or with another field therapy, the combination proved superior to monotherapy,” Dr. Rosen said. “It’s a little more work, but in the end I think it’s probably the best thing for your patient.”

Other Agents in the AK Pipeline. AK remains an active target for new drug development. Among the wide range of drugs in the developmental pipeline, albeit still years away from the marketplace, are:

P Resiquimod and sotirimod. These are the most promising of the more than 1,000 known analogues of imiquimod. Like the parent compound, they work via immune upregulation, said Dr. Rosen.

P Betulin. A triterpene isolated from the extract of birch bark. It eliminates actinic keratoses through cytotoxicity.

P Perillyl alcohol. A monoterpene isolated from essential oils of peppermint, spearmint, lavender, and other plants. Its mechanism of action involves induction of apoptosis in rapidly dividing cells without affecting normal cells.

P Difluoromethylornithine. Irreversibly inhibits ornithine decarboxylase, which regulates cell division. DFMO is already marketed in a topical formulation for the treatment of facial hirsutism, and as an injectable drug for treatment of African trypanosomiasis.

P Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.

P T4 endonuclease V. This drug enhances repair of UV-induced DNA damage. “It might help prevent future AKs, but not existing ones,” Dr. Rosen said.

Why does AK therapy remain such a busy area of new drug development? Simple: A substantial portion of the public continues to be casual about sun protection or disregards it altogether, and with the graying of the baby boomer generation, AKs are more common than ever, he said.

“Everybody in Texas has AKs, including me. I just found one on my hand, and now I need to go treat it,” he said.

Dr. Rosen is on the speaker’s bureau for Graceway and is a consultant to Graceway and Leo Pharmaceuticals. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Physicians will likely gain a novel short-course field therapy for multiple actinic keratoses next year.

Ingenol mebutate (Leo Pharmaceuticals) hit all of its end points in two phase III clinical trials. One trial was conducted in patients treated for fields of multiple actinic keratoses (AKs) on the head and neck, the other in patients with clusters of AKs anywhere else, Dr. Theodore Rosen said at a seminar sponsored by Skin Disease Education Foundation (SDEF).

Median reductions in AKs in these pivotal trials were comparable to results reported with other field therapies, such as imiquimod and 5-fluorouracil. What is remarkable about ingenol mebutate, however, is these outcomes were achieved with only 2 days of once-daily therapy for non–head and neck AKs and 3 days of therapy at a lower concentration for AKs on the head and neck, noted Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

In contrast, the original regimen for the 5% imiquimod dermatologists have been using since its 2004 marketing approval for AKs entails a full 16 weeks of twice-weekly therapy. That being said, last year, the FDA approved a new, shorter-duration formulation of imiquimod which Dr. Rosen said was a better product than the traditional 5% version.

Ingenol mebutate is a diterpene ester derived from the sap of a plant, Euphorbia peplus, traditionally used by Australian aborigines for topical treatment of various skin ailments. Ingenol mebutate’s mechanism of action is not fully understood, but involves initial cell necrosis because of mitochondrial disruption followed by granulocyte-dependent cytotoxicity. Immune upregulation also appears to be involved, Dr. Rosen explained.

Non–Head and Neck AK Study. The phase III non–head and neck AK study involved 256 patients randomized to 2 consecutive days of once-daily ingenol mebutate 0.05% gel or placebo applied to up to a 25-cm² area of skin with four to eight visible AKs. The ingenol mebutate group showed a complete clearance rate at day 57 of 27.8%, compared with 4.7% for placebo, and a median 67% reduction in AKs.

The 27.8% complete clearance rate is nothing to write home about, but the 67% reduction in AKs is quite impressive, particularly for a 2-day therapy, according to Dr. Rosen, who was an investigator in these and other AK clinical trials.

“That 67% median reduction is very nice, and it’s really the most accurate measurement because it tells you how many of these things are going to go away by treating the field,” Dr. Rosen said.

The complete clearance rate was highest on the chest, followed by the arms, legs, back of hand, and back.

Side effect rates were low at 1%-2%, and consisted of burning, irritation, pain, and other symptoms that are associated with most field therapies for AKs. Interestingly, the peak incidence of the skin side effects was not until day 8.

“You’ll have to prepare patients for the fact that almost a week after they’re done with therapy, they may suddenly look worse,” he noted.

The product labeling will limit treatment to areas of 25 cm² or less because that is how the pivotal trials were done. “If you want to treat more than 25 cm², you’ll probably be off-label, but we do that all the time,” he said.

In an exploratory trial in which investigators treated AK fields of 25, 50, 75, and 100 cm² on the dorsal arms using 0.05% ingenol mebutate applied once daily for 2 days, cumulative local skin reaction scores correlated with the size of the area treated. Even in patients who underwent treatment of 100 cm² of involved skin, side-effect scores returned to baseline by 2 months. Most patients tolerated even the most severe reactions, he noted.

Head and Neck AK Study. The phase III head and neck AK trial involved treatment of areas up to 25 cm² in 264 patients. This trial featured several drug concentrations and durations; the one that produced the best outcomes and will move forward to the marketplace is 0.015% once daily for 3 days. It yielded a complete clearance rate of 50% on day 57, and an 85% median reduction in AKs, according to Dr. Rosen.

With two different concentrations of ingenol mebutate likely to be approved for application at different sites, physicians will need to remain vigilant regarding possible dispensing errors or patient misuse, he said.

Imiquimod. While ingenol mebutate’s duration of efficacy remains unknown, that is not the case with imiquimod.

The new imiquimod 3.75% cream (Zyclara), approved last year for treatment of AKs, provides clear benefits over the older 5% formulation in terms of convenience, and with comparable efficacy.

Instead of the traditional 16 weeks of therapy, the 3.75% cream is used daily for 2 weeks, followed by a 2-week rest, then another 2 weeks of therapy, for a total 6-week treatment course. And the imiquimod 3.75% cream is approved for treatment of the full face or balding scalp, unlike imiquimod 5%, whose approved indication is limited to a much smaller area of 25 cm², Dr. Rosen said.

In the pivotal trial for imiquimod 3.75%, 160 treated patients showed a complete clearance rate of 35.6% and a median 81.8% reduction in AKs 8 weeks after the final treatment. That is near-identical to the 83.3% reduction noted in an earlier trial of 215 patients treated with imiquimod 5%.

Dr. Rosen said field therapy makes sound sense in patients with multiple AKs in the same area of the skin.

“When you have a patient with [a lot of] AKs, then all the skin in between those AKs is no more normal than the AK skin; it just hasn’t manifest yet. That’s where field therapy comes in,” he explained.

As much as he likes field therapy, though, Dr. Rosen stressed that the emerging new paradigm for treatment of patients with multiple AKs is combination therapy. This can take the form of either a field therapy followed by individual lesion-directed therapy such as cryotherapy, or lesion-directed therapy followed by a field therapy. There are numerous possible combinations. Insurance reimbursement can be a problem for now, but payers will eventually have to come around to the new paradigm.

“The bottom line is for every study where field therapy is combined with lesion-directed therapy or with another field therapy, the combination proved superior to monotherapy,” Dr. Rosen said. “It’s a little more work, but in the end I think it’s probably the best thing for your patient.”

Other Agents in the AK Pipeline. AK remains an active target for new drug development. Among the wide range of drugs in the developmental pipeline, albeit still years away from the marketplace, are:

P Resiquimod and sotirimod. These are the most promising of the more than 1,000 known analogues of imiquimod. Like the parent compound, they work via immune upregulation, said Dr. Rosen.

P Betulin. A triterpene isolated from the extract of birch bark. It eliminates actinic keratoses through cytotoxicity.

P Perillyl alcohol. A monoterpene isolated from essential oils of peppermint, spearmint, lavender, and other plants. Its mechanism of action involves induction of apoptosis in rapidly dividing cells without affecting normal cells.

P Difluoromethylornithine. Irreversibly inhibits ornithine decarboxylase, which regulates cell division. DFMO is already marketed in a topical formulation for the treatment of facial hirsutism, and as an injectable drug for treatment of African trypanosomiasis.

P Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.

P T4 endonuclease V. This drug enhances repair of UV-induced DNA damage. “It might help prevent future AKs, but not existing ones,” Dr. Rosen said.

Why does AK therapy remain such a busy area of new drug development? Simple: A substantial portion of the public continues to be casual about sun protection or disregards it altogether, and with the graying of the baby boomer generation, AKs are more common than ever, he said.

“Everybody in Texas has AKs, including me. I just found one on my hand, and now I need to go treat it,” he said.

Dr. Rosen is on the speaker’s bureau for Graceway and is a consultant to Graceway and Leo Pharmaceuticals. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Physicians will likely gain a novel short-course field therapy for multiple actinic keratoses next year.

Ingenol mebutate (Leo Pharmaceuticals) hit all of its end points in two phase III clinical trials. One trial was conducted in patients treated for fields of multiple actinic keratoses (AKs) on the head and neck, the other in patients with clusters of AKs anywhere else, Dr. Theodore Rosen said at a seminar sponsored by Skin Disease Education Foundation (SDEF).

Median reductions in AKs in these pivotal trials were comparable to results reported with other field therapies, such as imiquimod and 5-fluorouracil. What is remarkable about ingenol mebutate, however, is these outcomes were achieved with only 2 days of once-daily therapy for non–head and neck AKs and 3 days of therapy at a lower concentration for AKs on the head and neck, noted Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

In contrast, the original regimen for the 5% imiquimod dermatologists have been using since its 2004 marketing approval for AKs entails a full 16 weeks of twice-weekly therapy. That being said, last year, the FDA approved a new, shorter-duration formulation of imiquimod which Dr. Rosen said was a better product than the traditional 5% version.

Ingenol mebutate is a diterpene ester derived from the sap of a plant, Euphorbia peplus, traditionally used by Australian aborigines for topical treatment of various skin ailments. Ingenol mebutate’s mechanism of action is not fully understood, but involves initial cell necrosis because of mitochondrial disruption followed by granulocyte-dependent cytotoxicity. Immune upregulation also appears to be involved, Dr. Rosen explained.

Non–Head and Neck AK Study. The phase III non–head and neck AK study involved 256 patients randomized to 2 consecutive days of once-daily ingenol mebutate 0.05% gel or placebo applied to up to a 25-cm² area of skin with four to eight visible AKs. The ingenol mebutate group showed a complete clearance rate at day 57 of 27.8%, compared with 4.7% for placebo, and a median 67% reduction in AKs.

The 27.8% complete clearance rate is nothing to write home about, but the 67% reduction in AKs is quite impressive, particularly for a 2-day therapy, according to Dr. Rosen, who was an investigator in these and other AK clinical trials.

“That 67% median reduction is very nice, and it’s really the most accurate measurement because it tells you how many of these things are going to go away by treating the field,” Dr. Rosen said.

The complete clearance rate was highest on the chest, followed by the arms, legs, back of hand, and back.

Side effect rates were low at 1%-2%, and consisted of burning, irritation, pain, and other symptoms that are associated with most field therapies for AKs. Interestingly, the peak incidence of the skin side effects was not until day 8.

“You’ll have to prepare patients for the fact that almost a week after they’re done with therapy, they may suddenly look worse,” he noted.

The product labeling will limit treatment to areas of 25 cm² or less because that is how the pivotal trials were done. “If you want to treat more than 25 cm², you’ll probably be off-label, but we do that all the time,” he said.

In an exploratory trial in which investigators treated AK fields of 25, 50, 75, and 100 cm² on the dorsal arms using 0.05% ingenol mebutate applied once daily for 2 days, cumulative local skin reaction scores correlated with the size of the area treated. Even in patients who underwent treatment of 100 cm² of involved skin, side-effect scores returned to baseline by 2 months. Most patients tolerated even the most severe reactions, he noted.

Head and Neck AK Study. The phase III head and neck AK trial involved treatment of areas up to 25 cm² in 264 patients. This trial featured several drug concentrations and durations; the one that produced the best outcomes and will move forward to the marketplace is 0.015% once daily for 3 days. It yielded a complete clearance rate of 50% on day 57, and an 85% median reduction in AKs, according to Dr. Rosen.

With two different concentrations of ingenol mebutate likely to be approved for application at different sites, physicians will need to remain vigilant regarding possible dispensing errors or patient misuse, he said.

Imiquimod. While ingenol mebutate’s duration of efficacy remains unknown, that is not the case with imiquimod.

The new imiquimod 3.75% cream (Zyclara), approved last year for treatment of AKs, provides clear benefits over the older 5% formulation in terms of convenience, and with comparable efficacy.

Instead of the traditional 16 weeks of therapy, the 3.75% cream is used daily for 2 weeks, followed by a 2-week rest, then another 2 weeks of therapy, for a total 6-week treatment course. And the imiquimod 3.75% cream is approved for treatment of the full face or balding scalp, unlike imiquimod 5%, whose approved indication is limited to a much smaller area of 25 cm², Dr. Rosen said.

In the pivotal trial for imiquimod 3.75%, 160 treated patients showed a complete clearance rate of 35.6% and a median 81.8% reduction in AKs 8 weeks after the final treatment. That is near-identical to the 83.3% reduction noted in an earlier trial of 215 patients treated with imiquimod 5%.

Dr. Rosen said field therapy makes sound sense in patients with multiple AKs in the same area of the skin.

“When you have a patient with [a lot of] AKs, then all the skin in between those AKs is no more normal than the AK skin; it just hasn’t manifest yet. That’s where field therapy comes in,” he explained.

As much as he likes field therapy, though, Dr. Rosen stressed that the emerging new paradigm for treatment of patients with multiple AKs is combination therapy. This can take the form of either a field therapy followed by individual lesion-directed therapy such as cryotherapy, or lesion-directed therapy followed by a field therapy. There are numerous possible combinations. Insurance reimbursement can be a problem for now, but payers will eventually have to come around to the new paradigm.

“The bottom line is for every study where field therapy is combined with lesion-directed therapy or with another field therapy, the combination proved superior to monotherapy,” Dr. Rosen said. “It’s a little more work, but in the end I think it’s probably the best thing for your patient.”

Other Agents in the AK Pipeline. AK remains an active target for new drug development. Among the wide range of drugs in the developmental pipeline, albeit still years away from the marketplace, are:

P Resiquimod and sotirimod. These are the most promising of the more than 1,000 known analogues of imiquimod. Like the parent compound, they work via immune upregulation, said Dr. Rosen.

P Betulin. A triterpene isolated from the extract of birch bark. It eliminates actinic keratoses through cytotoxicity.

P Perillyl alcohol. A monoterpene isolated from essential oils of peppermint, spearmint, lavender, and other plants. Its mechanism of action involves induction of apoptosis in rapidly dividing cells without affecting normal cells.

P Difluoromethylornithine. Irreversibly inhibits ornithine decarboxylase, which regulates cell division. DFMO is already marketed in a topical formulation for the treatment of facial hirsutism, and as an injectable drug for treatment of African trypanosomiasis.

P Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.

P T4 endonuclease V. This drug enhances repair of UV-induced DNA damage. “It might help prevent future AKs, but not existing ones,” Dr. Rosen said.

Why does AK therapy remain such a busy area of new drug development? Simple: A substantial portion of the public continues to be casual about sun protection or disregards it altogether, and with the graying of the baby boomer generation, AKs are more common than ever, he said.

“Everybody in Texas has AKs, including me. I just found one on my hand, and now I need to go treat it,” he said.

Dr. Rosen is on the speaker’s bureau for Graceway and is a consultant to Graceway and Leo Pharmaceuticals. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Physicians will likely gain a novel short-course field therapy for multiple actinic keratoses next year.

Ingenol mebutate (Leo Pharmaceuticals) hit all of its end points in two phase III clinical trials. One trial was conducted in patients treated for fields of multiple actinic keratoses (AKs) on the head and neck, the other in patients with clusters of AKs anywhere else, Dr. Theodore Rosen said at a seminar sponsored by Skin Disease Education Foundation (SDEF).

Median reductions in AKs in these pivotal trials were comparable to results reported with other field therapies, such as imiquimod and 5-fluorouracil. What is remarkable about ingenol mebutate, however, is these outcomes were achieved with only 2 days of once-daily therapy for non–head and neck AKs and 3 days of therapy at a lower concentration for AKs on the head and neck, noted Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

In contrast, the original regimen for the 5% imiquimod dermatologists have been using since its 2004 marketing approval for AKs entails a full 16 weeks of twice-weekly therapy. That being said, last year, the FDA approved a new, shorter-duration formulation of imiquimod which Dr. Rosen said was a better product than the traditional 5% version.

Ingenol mebutate is a diterpene ester derived from the sap of a plant, Euphorbia peplus, traditionally used by Australian aborigines for topical treatment of various skin ailments. Ingenol mebutate’s mechanism of action is not fully understood, but involves initial cell necrosis because of mitochondrial disruption followed by granulocyte-dependent cytotoxicity. Immune upregulation also appears to be involved, Dr. Rosen explained.

Non–Head and Neck AK Study. The phase III non–head and neck AK study involved 256 patients randomized to 2 consecutive days of once-daily ingenol mebutate 0.05% gel or placebo applied to up to a 25-cm² area of skin with four to eight visible AKs. The ingenol mebutate group showed a complete clearance rate at day 57 of 27.8%, compared with 4.7% for placebo, and a median 67% reduction in AKs.

The 27.8% complete clearance rate is nothing to write home about, but the 67% reduction in AKs is quite impressive, particularly for a 2-day therapy, according to Dr. Rosen, who was an investigator in these and other AK clinical trials.

“That 67% median reduction is very nice, and it’s really the most accurate measurement because it tells you how many of these things are going to go away by treating the field,” Dr. Rosen said.

The complete clearance rate was highest on the chest, followed by the arms, legs, back of hand, and back.

Side effect rates were low at 1%-2%, and consisted of burning, irritation, pain, and other symptoms that are associated with most field therapies for AKs. Interestingly, the peak incidence of the skin side effects was not until day 8.

“You’ll have to prepare patients for the fact that almost a week after they’re done with therapy, they may suddenly look worse,” he noted.

The product labeling will limit treatment to areas of 25 cm² or less because that is how the pivotal trials were done. “If you want to treat more than 25 cm², you’ll probably be off-label, but we do that all the time,” he said.

In an exploratory trial in which investigators treated AK fields of 25, 50, 75, and 100 cm² on the dorsal arms using 0.05% ingenol mebutate applied once daily for 2 days, cumulative local skin reaction scores correlated with the size of the area treated. Even in patients who underwent treatment of 100 cm² of involved skin, side-effect scores returned to baseline by 2 months. Most patients tolerated even the most severe reactions, he noted.

Head and Neck AK Study. The phase III head and neck AK trial involved treatment of areas up to 25 cm² in 264 patients. This trial featured several drug concentrations and durations; the one that produced the best outcomes and will move forward to the marketplace is 0.015% once daily for 3 days. It yielded a complete clearance rate of 50% on day 57, and an 85% median reduction in AKs, according to Dr. Rosen.

With two different concentrations of ingenol mebutate likely to be approved for application at different sites, physicians will need to remain vigilant regarding possible dispensing errors or patient misuse, he said.

Imiquimod. While ingenol mebutate’s duration of efficacy remains unknown, that is not the case with imiquimod.

The new imiquimod 3.75% cream (Zyclara), approved last year for treatment of AKs, provides clear benefits over the older 5% formulation in terms of convenience, and with comparable efficacy.

Instead of the traditional 16 weeks of therapy, the 3.75% cream is used daily for 2 weeks, followed by a 2-week rest, then another 2 weeks of therapy, for a total 6-week treatment course. And the imiquimod 3.75% cream is approved for treatment of the full face or balding scalp, unlike imiquimod 5%, whose approved indication is limited to a much smaller area of 25 cm², Dr. Rosen said.

In the pivotal trial for imiquimod 3.75%, 160 treated patients showed a complete clearance rate of 35.6% and a median 81.8% reduction in AKs 8 weeks after the final treatment. That is near-identical to the 83.3% reduction noted in an earlier trial of 215 patients treated with imiquimod 5%.

Dr. Rosen said field therapy makes sound sense in patients with multiple AKs in the same area of the skin.

“When you have a patient with [a lot of] AKs, then all the skin in between those AKs is no more normal than the AK skin; it just hasn’t manifest yet. That’s where field therapy comes in,” he explained.

As much as he likes field therapy, though, Dr. Rosen stressed that the emerging new paradigm for treatment of patients with multiple AKs is combination therapy. This can take the form of either a field therapy followed by individual lesion-directed therapy such as cryotherapy, or lesion-directed therapy followed by a field therapy. There are numerous possible combinations. Insurance reimbursement can be a problem for now, but payers will eventually have to come around to the new paradigm.

“The bottom line is for every study where field therapy is combined with lesion-directed therapy or with another field therapy, the combination proved superior to monotherapy,” Dr. Rosen said. “It’s a little more work, but in the end I think it’s probably the best thing for your patient.”

Other Agents in the AK Pipeline. AK remains an active target for new drug development. Among the wide range of drugs in the developmental pipeline, albeit still years away from the marketplace, are:

P Resiquimod and sotirimod. These are the most promising of the more than 1,000 known analogues of imiquimod. Like the parent compound, they work via immune upregulation, said Dr. Rosen.

P Betulin. A triterpene isolated from the extract of birch bark. It eliminates actinic keratoses through cytotoxicity.

P Perillyl alcohol. A monoterpene isolated from essential oils of peppermint, spearmint, lavender, and other plants. Its mechanism of action involves induction of apoptosis in rapidly dividing cells without affecting normal cells.

P Difluoromethylornithine. Irreversibly inhibits ornithine decarboxylase, which regulates cell division. DFMO is already marketed in a topical formulation for the treatment of facial hirsutism, and as an injectable drug for treatment of African trypanosomiasis.

P Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.

P T4 endonuclease V. This drug enhances repair of UV-induced DNA damage. “It might help prevent future AKs, but not existing ones,” Dr. Rosen said.

Why does AK therapy remain such a busy area of new drug development? Simple: A substantial portion of the public continues to be casual about sun protection or disregards it altogether, and with the graying of the baby boomer generation, AKs are more common than ever, he said.

“Everybody in Texas has AKs, including me. I just found one on my hand, and now I need to go treat it,” he said.

Dr. Rosen is on the speaker’s bureau for Graceway and is a consultant to Graceway and Leo Pharmaceuticals. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Physicians will likely gain a novel short-course field therapy for multiple actinic keratoses next year.

Ingenol mebutate (Leo Pharmaceuticals) hit all of its end points in two phase III clinical trials. One trial was conducted in patients treated for fields of multiple actinic keratoses (AKs) on the head and neck, the other in patients with clusters of AKs anywhere else, Dr. Theodore Rosen said at a seminar sponsored by Skin Disease Education Foundation (SDEF).

Median reductions in AKs in these pivotal trials were comparable to results reported with other field therapies, such as imiquimod and 5-fluorouracil. What is remarkable about ingenol mebutate, however, is these outcomes were achieved with only 2 days of once-daily therapy for non–head and neck AKs and 3 days of therapy at a lower concentration for AKs on the head and neck, noted Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

In contrast, the original regimen for the 5% imiquimod dermatologists have been using since its 2004 marketing approval for AKs entails a full 16 weeks of twice-weekly therapy. That being said, last year, the FDA approved a new, shorter-duration formulation of imiquimod which Dr. Rosen said was a better product than the traditional 5% version.

Ingenol mebutate is a diterpene ester derived from the sap of a plant, Euphorbia peplus, traditionally used by Australian aborigines for topical treatment of various skin ailments. Ingenol mebutate’s mechanism of action is not fully understood, but involves initial cell necrosis because of mitochondrial disruption followed by granulocyte-dependent cytotoxicity. Immune upregulation also appears to be involved, Dr. Rosen explained.

Non–Head and Neck AK Study. The phase III non–head and neck AK study involved 256 patients randomized to 2 consecutive days of once-daily ingenol mebutate 0.05% gel or placebo applied to up to a 25-cm² area of skin with four to eight visible AKs. The ingenol mebutate group showed a complete clearance rate at day 57 of 27.8%, compared with 4.7% for placebo, and a median 67% reduction in AKs.

The 27.8% complete clearance rate is nothing to write home about, but the 67% reduction in AKs is quite impressive, particularly for a 2-day therapy, according to Dr. Rosen, who was an investigator in these and other AK clinical trials.

“That 67% median reduction is very nice, and it’s really the most accurate measurement because it tells you how many of these things are going to go away by treating the field,” Dr. Rosen said.

The complete clearance rate was highest on the chest, followed by the arms, legs, back of hand, and back.

Side effect rates were low at 1%-2%, and consisted of burning, irritation, pain, and other symptoms that are associated with most field therapies for AKs. Interestingly, the peak incidence of the skin side effects was not until day 8.

“You’ll have to prepare patients for the fact that almost a week after they’re done with therapy, they may suddenly look worse,” he noted.

The product labeling will limit treatment to areas of 25 cm² or less because that is how the pivotal trials were done. “If you want to treat more than 25 cm², you’ll probably be off-label, but we do that all the time,” he said.

In an exploratory trial in which investigators treated AK fields of 25, 50, 75, and 100 cm² on the dorsal arms using 0.05% ingenol mebutate applied once daily for 2 days, cumulative local skin reaction scores correlated with the size of the area treated. Even in patients who underwent treatment of 100 cm² of involved skin, side-effect scores returned to baseline by 2 months. Most patients tolerated even the most severe reactions, he noted.

Head and Neck AK Study. The phase III head and neck AK trial involved treatment of areas up to 25 cm² in 264 patients. This trial featured several drug concentrations and durations; the one that produced the best outcomes and will move forward to the marketplace is 0.015% once daily for 3 days. It yielded a complete clearance rate of 50% on day 57, and an 85% median reduction in AKs, according to Dr. Rosen.

With two different concentrations of ingenol mebutate likely to be approved for application at different sites, physicians will need to remain vigilant regarding possible dispensing errors or patient misuse, he said.

Imiquimod. While ingenol mebutate’s duration of efficacy remains unknown, that is not the case with imiquimod.

The new imiquimod 3.75% cream (Zyclara), approved last year for treatment of AKs, provides clear benefits over the older 5% formulation in terms of convenience, and with comparable efficacy.

Instead of the traditional 16 weeks of therapy, the 3.75% cream is used daily for 2 weeks, followed by a 2-week rest, then another 2 weeks of therapy, for a total 6-week treatment course. And the imiquimod 3.75% cream is approved for treatment of the full face or balding scalp, unlike imiquimod 5%, whose approved indication is limited to a much smaller area of 25 cm², Dr. Rosen said.

In the pivotal trial for imiquimod 3.75%, 160 treated patients showed a complete clearance rate of 35.6% and a median 81.8% reduction in AKs 8 weeks after the final treatment. That is near-identical to the 83.3% reduction noted in an earlier trial of 215 patients treated with imiquimod 5%.

Dr. Rosen said field therapy makes sound sense in patients with multiple AKs in the same area of the skin.

“When you have a patient with [a lot of] AKs, then all the skin in between those AKs is no more normal than the AK skin; it just hasn’t manifest yet. That’s where field therapy comes in,” he explained.

As much as he likes field therapy, though, Dr. Rosen stressed that the emerging new paradigm for treatment of patients with multiple AKs is combination therapy. This can take the form of either a field therapy followed by individual lesion-directed therapy such as cryotherapy, or lesion-directed therapy followed by a field therapy. There are numerous possible combinations. Insurance reimbursement can be a problem for now, but payers will eventually have to come around to the new paradigm.

“The bottom line is for every study where field therapy is combined with lesion-directed therapy or with another field therapy, the combination proved superior to monotherapy,” Dr. Rosen said. “It’s a little more work, but in the end I think it’s probably the best thing for your patient.”

Other Agents in the AK Pipeline. AK remains an active target for new drug development. Among the wide range of drugs in the developmental pipeline, albeit still years away from the marketplace, are:

P Resiquimod and sotirimod. These are the most promising of the more than 1,000 known analogues of imiquimod. Like the parent compound, they work via immune upregulation, said Dr. Rosen.

P Betulin. A triterpene isolated from the extract of birch bark. It eliminates actinic keratoses through cytotoxicity.

P Perillyl alcohol. A monoterpene isolated from essential oils of peppermint, spearmint, lavender, and other plants. Its mechanism of action involves induction of apoptosis in rapidly dividing cells without affecting normal cells.

P Difluoromethylornithine. Irreversibly inhibits ornithine decarboxylase, which regulates cell division. DFMO is already marketed in a topical formulation for the treatment of facial hirsutism, and as an injectable drug for treatment of African trypanosomiasis.

P Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.

P T4 endonuclease V. This drug enhances repair of UV-induced DNA damage. “It might help prevent future AKs, but not existing ones,” Dr. Rosen said.

Why does AK therapy remain such a busy area of new drug development? Simple: A substantial portion of the public continues to be casual about sun protection or disregards it altogether, and with the graying of the baby boomer generation, AKs are more common than ever, he said.

“Everybody in Texas has AKs, including me. I just found one on my hand, and now I need to go treat it,” he said.

Dr. Rosen is on the speaker’s bureau for Graceway and is a consultant to Graceway and Leo Pharmaceuticals. SDEF and this news organization are owned by Elsevier.

WAILEA, HAWAII – Physicians will likely gain a novel short-course field therapy for multiple actinic keratoses next year.

Ingenol mebutate (Leo Pharmaceuticals) hit all of its end points in two phase III clinical trials. One trial was conducted in patients treated for fields of multiple actinic keratoses (AKs) on the head and neck, the other in patients with clusters of AKs anywhere else, Dr. Theodore Rosen said at a seminar sponsored by Skin Disease Education Foundation (SDEF).

Median reductions in AKs in these pivotal trials were comparable to results reported with other field therapies, such as imiquimod and 5-fluorouracil. What is remarkable about ingenol mebutate, however, is these outcomes were achieved with only 2 days of once-daily therapy for non–head and neck AKs and 3 days of therapy at a lower concentration for AKs on the head and neck, noted Dr. Rosen, professor of dermatology at Baylor College of Medicine, Houston.

In contrast, the original regimen for the 5% imiquimod dermatologists have been using since its 2004 marketing approval for AKs entails a full 16 weeks of twice-weekly therapy. That being said, last year, the FDA approved a new, shorter-duration formulation of imiquimod which Dr. Rosen said was a better product than the traditional 5% version.

Ingenol mebutate is a diterpene ester derived from the sap of a plant, Euphorbia peplus, traditionally used by Australian aborigines for topical treatment of various skin ailments. Ingenol mebutate’s mechanism of action is not fully understood, but involves initial cell necrosis because of mitochondrial disruption followed by granulocyte-dependent cytotoxicity. Immune upregulation also appears to be involved, Dr. Rosen explained.

Non–Head and Neck AK Study. The phase III non–head and neck AK study involved 256 patients randomized to 2 consecutive days of once-daily ingenol mebutate 0.05% gel or placebo applied to up to a 25-cm² area of skin with four to eight visible AKs. The ingenol mebutate group showed a complete clearance rate at day 57 of 27.8%, compared with 4.7% for placebo, and a median 67% reduction in AKs.

The 27.8% complete clearance rate is nothing to write home about, but the 67% reduction in AKs is quite impressive, particularly for a 2-day therapy, according to Dr. Rosen, who was an investigator in these and other AK clinical trials.

“That 67% median reduction is very nice, and it’s really the most accurate measurement because it tells you how many of these things are going to go away by treating the field,” Dr. Rosen said.

The complete clearance rate was highest on the chest, followed by the arms, legs, back of hand, and back.

Side effect rates were low at 1%-2%, and consisted of burning, irritation, pain, and other symptoms that are associated with most field therapies for AKs. Interestingly, the peak incidence of the skin side effects was not until day 8.

“You’ll have to prepare patients for the fact that almost a week after they’re done with therapy, they may suddenly look worse,” he noted.

The product labeling will limit treatment to areas of 25 cm² or less because that is how the pivotal trials were done. “If you want to treat more than 25 cm², you’ll probably be off-label, but we do that all the time,” he said.

In an exploratory trial in which investigators treated AK fields of 25, 50, 75, and 100 cm² on the dorsal arms using 0.05% ingenol mebutate applied once daily for 2 days, cumulative local skin reaction scores correlated with the size of the area treated. Even in patients who underwent treatment of 100 cm² of involved skin, side-effect scores returned to baseline by 2 months. Most patients tolerated even the most severe reactions, he noted.

Head and Neck AK Study. The phase III head and neck AK trial involved treatment of areas up to 25 cm² in 264 patients. This trial featured several drug concentrations and durations; the one that produced the best outcomes and will move forward to the marketplace is 0.015% once daily for 3 days. It yielded a complete clearance rate of 50% on day 57, and an 85% median reduction in AKs, according to Dr. Rosen.

With two different concentrations of ingenol mebutate likely to be approved for application at different sites, physicians will need to remain vigilant regarding possible dispensing errors or patient misuse, he said.

Imiquimod. While ingenol mebutate’s duration of efficacy remains unknown, that is not the case with imiquimod.

The new imiquimod 3.75% cream (Zyclara), approved last year for treatment of AKs, provides clear benefits over the older 5% formulation in terms of convenience, and with comparable efficacy.

Instead of the traditional 16 weeks of therapy, the 3.75% cream is used daily for 2 weeks, followed by a 2-week rest, then another 2 weeks of therapy, for a total 6-week treatment course. And the imiquimod 3.75% cream is approved for treatment of the full face or balding scalp, unlike imiquimod 5%, whose approved indication is limited to a much smaller area of 25 cm², Dr. Rosen said.

In the pivotal trial for imiquimod 3.75%, 160 treated patients showed a complete clearance rate of 35.6% and a median 81.8% reduction in AKs 8 weeks after the final treatment. That is near-identical to the 83.3% reduction noted in an earlier trial of 215 patients treated with imiquimod 5%.

Dr. Rosen said field therapy makes sound sense in patients with multiple AKs in the same area of the skin.

“When you have a patient with [a lot of] AKs, then all the skin in between those AKs is no more normal than the AK skin; it just hasn’t manifest yet. That’s where field therapy comes in,” he explained.

As much as he likes field therapy, though, Dr. Rosen stressed that the emerging new paradigm for treatment of patients with multiple AKs is combination therapy. This can take the form of either a field therapy followed by individual lesion-directed therapy such as cryotherapy, or lesion-directed therapy followed by a field therapy. There are numerous possible combinations. Insurance reimbursement can be a problem for now, but payers will eventually have to come around to the new paradigm.

“The bottom line is for every study where field therapy is combined with lesion-directed therapy or with another field therapy, the combination proved superior to monotherapy,” Dr. Rosen said. “It’s a little more work, but in the end I think it’s probably the best thing for your patient.”

Other Agents in the AK Pipeline. AK remains an active target for new drug development. Among the wide range of drugs in the developmental pipeline, albeit still years away from the marketplace, are:

P Resiquimod and sotirimod. These are the most promising of the more than 1,000 known analogues of imiquimod. Like the parent compound, they work via immune upregulation, said Dr. Rosen.

P Betulin. A triterpene isolated from the extract of birch bark. It eliminates actinic keratoses through cytotoxicity.

P Perillyl alcohol. A monoterpene isolated from essential oils of peppermint, spearmint, lavender, and other plants. Its mechanism of action involves induction of apoptosis in rapidly dividing cells without affecting normal cells.

P Difluoromethylornithine. Irreversibly inhibits ornithine decarboxylase, which regulates cell division. DFMO is already marketed in a topical formulation for the treatment of facial hirsutism, and as an injectable drug for treatment of African trypanosomiasis.

P Afamelanotide. This synthetic analogue of melanocyte-stimulating hormone is under development as a treatment for a diverse collection of skin diseases, including polymorphous light eruption, solar urticaria, and squamous cell carcinoma, as well as AKs.

P T4 endonuclease V. This drug enhances repair of UV-induced DNA damage. “It might help prevent future AKs, but not existing ones,” Dr. Rosen said.

Why does AK therapy remain such a busy area of new drug development? Simple: A substantial portion of the public continues to be casual about sun protection or disregards it altogether, and with the graying of the baby boomer generation, AKs are more common than ever, he said.

“Everybody in Texas has AKs, including me. I just found one on my hand, and now I need to go treat it,” he said.

Dr. Rosen is on the speaker’s bureau for Graceway and is a consultant to Graceway and Leo Pharmaceuticals. SDEF and this news organization are owned by Elsevier.